A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients.

CompletadoFase 3ClinicalTrials.gov

ID: NCT01395901Tipo: INTERVENTIONALInicio: 1 de jun de 2011Fin estimado: 1 de abr de 2012

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.

Elegibilidad

Edad máxima: 16 YearsSexo: ALL

Criterios de inclusión

ASA physical status I, II or III
Patient weighs at least 3.2 kg
Male or female patient aged from full term neonate to less than 17 years.
In-patient or out-patient scheduled to undergo one of the following procedures:
ear, nose and throat surgery (e.g., tonsillectomy, adenoidectomy, myringotomy),
eye surgery (e.g. strabismus, vitreoretinal, cataract surgery),
urological surgery (e.g. orchidopexy, varicocoele),
plastic reconstructive surgery (e.g. cleft lip/cleft palate, burn procedures involving the scalp),
hernia repair,
orthopedic surgery (e.g. foot and ankle deformities, arthroscopic surgeries, ACL surgery),.
cardiac surgery,
neurosurgery.
Patient is scheduled to undergo surgery requiring general intravenous anesthesia
Patient is scheduled to receive nitrous oxide during the maintenance phase of anesthesia
Fertile patients (male or female) must use reliable contraceptive measures
Female patients who have attained menarche must have a negative pregnancy test at the screening visit (Visit 1) and at study treatment visit (Visit 2)
For patients with known hepatic impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study
For patients with known renal impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study

Criterios de exclusión

Lactating females
Patient aged ≤6 years who received any investigational drug within 90 days prior to Day 1, or patient aged \>6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion.
Patient having participated in any previous trial with palonosetron.
History of allergy to any components or any other contraindications to the use of any 5-HT3 receptor antagonists
Patient to undergo emergency surgery
Patient scheduled to receive regional anesthesia (lumbar, epidural, spinal) alone or in conjunction with general intravenous anesthesia
Patient scheduled to receive laryngeal mask anesthesia
Patient scheduled to receive propofol during the maintenance phase of anesthesia
Patient suffering from any concomitant disease uncontrolled by therapy, which, in the judgment of the Investigator, could compromise the outcome of surgery
Patient with history of gastro-esophageal reflux (except for patients up to 12 months)
Patient with ongoing vomiting from any organic cause
Patient having experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug

Intervenciones

drug

Palonosetron

Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)

drug

Ondansetron

Single dose Ondansetron IV: * 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg; * 13 years to less than 17 years dose: 4 mg

drug

Placebo to Ondansetron

drug

Placebo to Palonosetron

Ubicaciones

CEMIC, Otorhinolaryngology Department

Buenos Aires, Argentina

Istituto Medico Rio Cuarto

Río Cuarto, Argentina

Patrocinadores

PrincipalHelsinn Healthcare SA

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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